UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023862 |
|---|---|
| Receipt number | R000027484 |
| Scientific Title | A Comparative study of efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops. |
| Date of disclosure of the study information | 2016/09/07 |
| Last modified on | 2019/03/08 11:38:23 |
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Basic information
Public title
A Comparative study of efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops.
Acronym
A Comparative study of efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops.
Scientific Title
A Comparative study of efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops.
Scientific Title:Acronym
A Comparative study of efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops.
Region
| Japan |
Condition
Condition
primary open angle glaucoma or ocular hypertension
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate and compare efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops in patients with primary open angle glaucoma or ocular hypertension in a multi-center exploratory clinical study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IOP Change from baseline at the end of treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tapcom combination ophthalmic solution, QD for 12weeks
Interventions/Control_2
Xalacom combination eye drops, QD for 12weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who can visit the hospital according to the observation/test schedule determined in the study protocol
Those with disease of which the principal investigator or subinvestigator considers requiring treatment by using a fixed dose combination drug containing a prostaglandin and a beta blocker.
Key exclusion criteria
There is risk of visual field disorder drastically progressing during the study period.
Has retinal which may aggravate during the study period.
Has active extraocular disease, inflammation or infection of the eye or eyelids
Has corneal abnormalities or other diseases which would prohibit accurate IOP measurement by Goldmann applanation tonometer
Has undergone LASIK surgery
Patients who are contraindicated to beta blockers (those who with bronchial asthma or insufficiently controlled heart failure)
Patients with allergy to the ingredients used in the present study
Female who is pregnant, lactating, or may possibly be pregnant , wishes to become pregnant during the study period, or cannot use appropriate contraceptive method.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayo Hashimoto |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs, Development Management Department, Japan Business
Zip code
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
clinical@santen.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naomi Otsuka |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs, Development Management Department, Japan Business
Zip code
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9603
Homepage URL
clinical@santen.co.jp
Sponsor or person
Institute
Santen Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Medical Adviser, Yasuaki Kuwayama, Fukushima eye clinic(Osaka)
Management information
Registered date
| 2016 | Year | 08 | Month | 31 | Day |
Last modified on
| 2019 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027484
